Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis - Full Text View

Purpose

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis

Condition	Intervention	Phase
Postmenopausal Women With Osteoporosis	Drug: AMG 785 Drug: Alendronate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Bone Diseases Fractures Osteoporosis

Drug Information available for: Alendronate sodium

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of clinical fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ] [ Designated as safety issue: No ]
Event driven
Incidence of new vertebral fracture [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of fracture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percent changes in DXA Bone Mineral Density from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incidence of fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ] [ Designated as safety issue: No ]
Event driven
Percent changes in DXA Bone Mineral Density from baseline to 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Percent changes in DXA Bone Mineral Density from baseline to 36 months [ Time Frame: 36 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	May 2012
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AMG 785 AMG 785 sub-cutaneous injections and placebo alendronate (oral) for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)	Drug: AMG 785 AMG 785 sub-cutaneous injections and placebo alendronate (oral) for 12 months followed by open-label alendronate (oral) for at least another 12 months (until end of study) Other Name: sclerostin anitbody
Active Comparator: Alendronate Oral alendronate plus placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)	Drug: Alendronate Oral alendronate and placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate, (oral) for at least another 12 months (until end of study) Other Name: biophosphantes, Fosamax

Eligibility

Ages Eligible for Study:	60 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory postmenopausal women with osteoporosis (defined as low bone mineral density) and at least one vertebral fracture

Exclusion Criteria:

History of metabolic or bone disease (except osteoporosis) Use of agents affecting bone metabolism Vitamin D insufficiency History of solid organ or bone marrow transplants Hyper- or hypocalcemia Hyper- or hypothyroidism Hyper- or hypoparathyroidism Possible signs of intolerance to Alendronate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631214

Contacts

Contact: Amgen Call Center

866-572-6436

Show 201 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01631214 History of Changes
Other Study ID Numbers:	20110142, 2011-003142-41
Study First Received:	May 24, 2012
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Brazil: Ministry of Health Mexico: Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica European Union: European Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration New Zealand: Medsafe Mexico: Federal Commission for Protection Against Health Risks Peru: Instituto Nacional de Salud Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Denmark: National Board of Health Estonia: The State Agency of Medicine Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Spain: Agencia Espa?ola de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Ministry of Health Greece: Ministry of Health and Welfare Hong Kong: Department of Health Netherlands: Ministry of Health, Welfare and Sport Russia: Ministry of Health of the Russian Federation South Africa: Department of Health

Keywords provided by Amgen:

Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013